MAUDE Adverse Event Report: BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 81600N

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

The customer did not supply any patient demographics such as age, date of birth, sex or weight.(b)(6).A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's site.Hs (high sensitivity) system check failed, flyers on qc and samples were observed during precision run.The bec fse performed a major preventive maintenance (pm), a substrate decontamination and replaced the substrate pump valve and the precision pump upper piston spring.The major pm substrate decontamination and substrate pump valve and precision pump upper piston spring replacement resolved customer's issue.After all repairs and maintenance was completed, the instrument met all specifications.In conclusion, although it was not possible to identify one specific reason for the non-repeatable elevated access accutni+3 results observed, there is sufficient evidence to reasonably suggest a hardware malfunction is the cause of this event.All mdrs associated with this report are: 2122870-2016-00532, 2122870-2016-00533, 2122870-2016-00534, 2122870-2016-00535, 2122870-2016-00536, 2122870-2016-00537.(b)(4).

Event Description

The customer reported obtaining non-reproducible troponin i (access accutni+3) results for ten (10) patients involving the laboratory's access 2 immunoassay system (serial number (b)(4)).For patient 3, addressed in this report, the customer obtained one (1) result above the assay's normal reference range.The same patient's sample was analyzed one (1) time on an alternate access 2 immunoassay system at an external laboratory and recovered with one lower result within the assay's normal reference range.The elevated access accutni+3 result was released from the laboratory.There was report of change in patient treatment associated with this event.Patient 3 was admitted to the hospital.There was no report of additional injury to the patient in association with this event.This mdr addresses the results obtained on (b)(6) 2016 for patient 3.Mfr #2122870-2016-00533 addresses the results obtained on (b)(6) 2016 for patient 1.Mfr #2122870-2016-00534 addresses the results obtained on (b)(6) 2016 for patient 2.Mfr #2122870-2016-00536 addresses the results obtained on (b)(6) 2016 for patient 7.Mfr #2122870-2016-00537 addresses the results obtained on (b)(6) 2016 for patient 8.Mfr #2122870-2016-00532 addresses the results obtained on (b)(6) 2016 for five (5) patients, identified as patient 4, patient 5, patient 6, patient 9 and patient 10.Calibration, qc (quality control) and system check parameters were all recovering within expected ranges at the time of the event.The patient's samples were collected in becton dickinson edta tubes and were centrifuged at 3,500 rpm (rotations per minute) for ten (10) minutes at room temperature.No issues with sample integrity were reported by the customer.A beckman coulter field service engineer (fse) was dispatched to address instrument performances.

• Brand Name: ACCESS IMMUNOASSAY SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer Contact: angela kilian ; 1000 lake hazeltine drive; chaska 55318 ; 9523681330
• MDR Report Key: 6095687
• MDR Text Key: 59718980
• Report Number: 2122870-2016-00535
• Device Sequence Number: 0
• Product Code: MMI
• Reporter Country Code: EI
• PMA/PMN Number: K922823/A007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81600N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other